Senior Design Quality Engineer
3 weeks ago
- Bachelor's Degree in Engineering or Scientific related field
- 4+ years of Quality Engineering, Quality Manufacturing, and/or R&D experience
- Hands-on experience with Design Assurance, including Design Controls, Design Freeze (or pre- design freeze feasibility testing), Design Verification & Validation, and/or Design Test Method Development.
- Experience working within a highly regulated industry.
- Working knowledge of Software Development Life Cycle Processes in accordance with IEC 62304, highly preferred.
- Working knowledge of Usability Engineering Processes in accordance with IEC 62366, highly preferred.
- Experience leading design assurance and development activities which could include engineering studies, feasibility testing, drawing reviews for new product development programs.
- Leadership role in the creation and maintenance of risk management files in accordance with ISO 14971 and applicable regulations (plans, hazard analyses, FMEAs, software hazard analysis, reports, etc.)
- Develop QA specifications, test methods, inspection procedures, sampling plans, and related written procedures.
- Lead test method development and validation activities.
- Support new product launch, master validation plans, product V&V, process validations, and design transfer into manufacturing.
- Daily support of production requirements and issues through active involvement and presence in the assembly operations.
- Continual improvement of methods and systems towards full compliance and world class manufacturing.
- Implement and review changes to existing products, SOPs, Work Instructions, Test Methods, Process Changes, Design Changes, Labeling, and Field Issues to define the requirements for regulatory submissions and notifications.
- Support and prepare documentation for regulatory submissions and worldwide registrations
Occupational Category: Engineers, All Other
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